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Hologic Receives CE Mark for Cytology Slide, Molecular Sample Preparation Instrument

NEW YORK (360Dx) – Hologic said today that it has received a CE IVD mark in Europe for its ThinPrep Genesis processor, an instrument that prepares slides for cytology and aliquot samples for molecular testing, reducing manual sample handling.

Compared to older instruments, the ThinPrep Genesis processor has increased automation capabilities and provides ergonomic and chain-of-custody benefits, the firm said. The processor provides automated barcoding of samples, ensuring accurate sample tracking and reducing manual steps, and its increased automation is expected to deliver ergonomic benefits by reducing repetitive strain, the firm said.

Hologic supplies ThinPrep Pap tests and Aptima HPV tests that can be used independently or together for co-testing on the same sample to screen for cervical pre-cancer and cancer.

"The launch of the ThinPrep Genesis processor reflects our ongoing commitment to helping our lab customers deliver accurate and reliable results to clinicians and patients, while maximizing their operational efficiency," Jan Verstreken, Hologic's regional president for Canada and Europe, the Middle East, and Africa, said in a statement.

The Genesis processor is the latest extension of its ThinPrep portfolio, which consists of the first liquid-based Pap test for cervical cancer screening launched in 1996, Hologic said. It launched an updated ThinPrep 2000 processor in 2017 and received US Food and Drug Administration premarket approval in 2018 for the ThinPrep Integrated Imager, which guides cytotechnologists to areas showing potentially abnormal cells.